Trial Watch; Feb 2026 Edition 3
Early-February U.S. Clinical Trial Activity
This report summarises Phase 1–4 clinical trials in breast cancer, prostate cancer, Alzheimer's disease, Parkinson's disease, colon cancer and related areas that were newly announced, initiated or highlighted in news reports between 1 and 15 February 2026. The focus is on Phase 2 and Phase 3 trials, but Phase 1 and Phase 4 studies are included for completeness when relevant.
Therapeutic Areas Covered
Prostate Cancer
3 trialsTeverelix; Phase 2b Dose-Optimisation Trial
GnRH antagonist for advanced prostate cancer with high cardiovascular risk
What's new
On 10 Feb 2026 Medicus Pharma reported that the FDA gave a "study may proceed" clearance to start this U.S. Phase 2b trial. The study will enroll ~40 men with advanced prostate cancer who have high cardiovascular risk. It uses an intramuscular + subcutaneous loading dose of the GnRH antagonist teverelix, followed by maintenance injections every six weeks. The primary endpoint is achieving medical castration by Day 29 and maintaining suppression through Day 155. The dose-optimisation data will inform a larger Phase 3 program.
Why it matters
This trial addresses an important unmet need: prostate cancer patients with high cardiovascular risk who may face additional complications from existing hormonal therapies. The dose-optimisation design will guide Phase 3 development.
STRIKE-001 (KTX-2001); Phase 1 Update
NSD2 inhibitor for metastatic castration-resistant prostate cancer
What's new
In a release on 5 Feb 2026, K36 Therapeutics said it completed dosing of the first patient cohort in its STRIKE-001 trial evaluating the NSD2 inhibitor KTX-2001 for metastatic castration-resistant prostate cancer (mCRPC). The multi-centre, open-label study enrolls about 140 patients in two parts: Part A tests KTX-2001 monotherapy and Part B combines KTX-2001 with darolutamide. Primary objectives include safety and determination of the recommended Phase 2 dose; secondary objectives assess pharmacokinetics and pharmacodynamics.
Why it matters
Although this is not a new trial, dosing of the first cohort and site activation progress were highlighted, demonstrating continued momentum in targeting NSD2 for mCRPC.
ANDROMEDA Trial; Phase 2 (Continued Recruitment)
Lutetium-177 vs Actinium-225 PSMA-617 with SBRT for oligorecurrent prostate cancer
What's new
While the ANDROMEDA trial was announced in January 2026, UCLA Health continued promoting it. This Phase 2 study compares lutetium-177–PSMA-617 vs actinium-225–PSMA-617 given with stereotactic body radiotherapy (SBRT) for oligorecurrent prostate cancer. Men with recurrent prostate cancer in 1–5 sites receive SBRT and either two cycles of lutetium-177 therapy or a single cycle of actinium-225 therapy. The trial aims to determine which radiopharmaceutical provides more durable cancer control while delaying hormone therapy.
Why it matters
Although announced earlier, the trial remained a key Phase 2 study recruiting participants during February. It is one of the first randomized studies comparing alpha-emitting and beta-emitting PSMA therapies.
Breast Cancer / Women's Health
1 trialMagSense® HER2-Targeted Imaging Agent; Phase 2 (Planned)
Iron-oxide nanoparticle imaging for HER2-positive breast cancer
What's new
On 3 Feb 2026, Imagion Biosystems filed an Investigational New Drug application to the FDA for its MagSense® imaging agent. The company expects to begin a Phase 2 trial in U.S. HER2-positive breast-cancer patients pending FDA approval. The trial will use iron-oxide nanoparticles and magnetic resonance imaging to detect nodal metastases in HER2+ breast cancer. It will evaluate safety, imaging performance and diagnostic accuracy versus standard methods. Site activation was underway and enrolment could start as early as Q1 2026.
Why it matters
This planned diagnostic imaging trial underscores interest in non-therapeutic clinical trials that could improve cancer staging and treatment planning for HER2-positive breast cancer.
Alzheimer's Disease
2 trialsAlzheimer's Tau Platform (ATP); AADvac1; Phase 2
Active tau vaccine alone and in combination with anti-amyloid antibody
What's new
On 4 Feb 2026, a BioSpace report noted that NIH's Alzheimer's Tau Platform chose Axon Neuroscience's active tau vaccine AADvac1 as the first therapy for this U.S. platform trial. The trial will evaluate AADvac1 alone and in combination with an approved anti-amyloid antibody in people with early-stage Alzheimer's disease. The NIH-funded study will enrol up to 450 participants aged 50–80 with late preclinical or early prodromal Alzheimer's.
Why it matters
It aims to test whether combining tau and amyloid therapies improves outcomes, representing a new Phase 2 combination strategy and reflecting a trend towards multi-target approaches in Alzheimer's treatment.
CALMA Trial; IGC-AD1; Phase 2 (Enrollment Update)
Cannabinoid-based therapy for agitation in Alzheimer's disease
What's new
IGC Pharma announced on 2 Feb 2026 that its CALMA trial evaluating the cannabinoid-based therapy IGC-AD1 for agitation in Alzheimer's disease reached ~70% of planned enrolment. On 9 Feb 2026, the company said it expanded the trial to Colombia's Grupo de Neurociencias de Antioquia while continuing recruitment across 23 active sites in the U.S. and Canada. CALMA is a randomized, double-blind Phase 2 trial testing IGC-AD1 versus placebo in agitation associated with Alzheimer's disease.
Why it matters
Completing enrolment by mid-2026 is the final operational milestone before database lock. Expansion to Colombia adds genetic-mutation diversity and demonstrates continued progress.
Parkinson's Disease
1 trialREPLACE Trial; RNDP-001 Cell Therapy; Phase 1 (Recruitment Update)
iPSC-derived dopaminergic neuron therapy for moderate to severe Parkinson's disease
What's new
A Parkinson's News Today article on 9 Feb 2026 reported that the REPLACE trial (NCT07106021) is recruiting up to 12 adults with moderate to severe Parkinson's disease at USC's Keck School of Medicine, the University of Arizona and Ohio State University. The trial uses RNDP-001, a cell-replacement therapy derived from induced pluripotent stem cells that differentiate into dopamine-producing neurons. Patients receive stereotactic brain injections of low or high doses. The study primarily assesses safety and tolerability over 12–15 months, with long-term follow-up for up to five years.
Why it matters
Although dosing began in late 2025, recruitment and reporting continued into February 2026. This cell-replacement approach represents an innovative mechanism of action for Parkinson's disease.
Colon Cancer and Related Gastrointestinal Cancers
0 trialsLimited New U.S. Trial Announcements During the Period
Searches of clinical-trial news from February 1–15 2026 did not identify new Phase 2 or Phase 3 U.S. trials for colon or colorectal cancer. The only significant GI-cancer development in this window was Mabwell's previously noted Phase I/II trial of the antibody–drug conjugate 7MW4911 for advanced colorectal cancer, which began dosing in January 2026 (reported in the January summary). No new Phase 3 or Phase 4 trials were announced.
Phase 3 and Phase 4 Trials
Breast and Prostate: No new U.S. Phase 3 or Phase 4 therapeutic trials were announced in early February 2026. Regulatory updates and results from existing Phase 3 studies (e.g., Dato-DXd priority review, hot-flash management trial) were reported, but they were not new trial launches.
Alzheimer's, Parkinson's, Colon: Similarly, there were no new Phase 3 or Phase 4 trial announcements in these indications during February 1–15 2026.
Observations and Trends
Early-phase focus: Most clinical-trial news in early February centred on Phase 1 and Phase 2 studies, particularly innovative mechanisms of action. Examples include the NSD2 inhibitor KTX-2001 for mCRPC, the GnRH antagonist teverelix with cardiovascular-safety ambitions and the cell-replacement therapy RNDP-001 for Parkinson's.
Combination and platform trials: The Alzheimer's Tau Platform aims to test AADvac1 both alone and in combination with anti-amyloid therapy, reflecting a trend towards multi-target approaches. Combination radiopharmaceutical therapy in the ANDROMEDA trial continues to innovate in prostate cancer.
Diagnostic imaging trials: The planned MagSense® Phase 2 trial for HER2-positive breast cancer underscores interest in non-therapeutic clinical trials that could improve cancer staging and treatment planning.
Absence of Phase 3/4 announcements: No new U.S. Phase 3 or Phase 4 therapeutic trials were announced in prostate cancer, breast cancer, Alzheimer's, Parkinson's or colon cancer during February 1–15 2026, underscoring the need to watch for later-phase developments as early-phase data mature.
Trial Watch by Kitsa
Tracking early-phase clinical trials shaping the future of drug development. In summary, early February saw a strong focus on Phase 2 innovation, including Medicus Pharma's upcoming teverelix dose-optimization trial for high-risk prostate cancer, Imagion Biosystems' planned Phase 2 MagSense diagnostic trial in HER2-positive breast cancer and NIH's Tau Platform study incorporating Axon Neuroscience's AADvac1 vaccine. Progress updates on ongoing trials; such as IGC Pharma's CALMA study for Alzheimer's agitation and K36 Therapeutics' STRIKE-001 mCRPC trial; further illustrate the dynamic early-phase pipeline.
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